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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Events & Training

As a regulatory professional, you play a pivotal role throughout the product lifecycle and are increasingly being called on to provide leadership and knowledget to our organization. That's why RAPS' education and training resources include proprietary content created from real-world regulatory competency requirements.

RAPS offers educational resources and activities on topics that reflect your scope of pracitce in live and virtual forums. Content is developmed with a singular purpose - to increase your knowledge, competence and performance. And RAPS members get discounts on all educational products and training.

Books

Fundamentals of Regulatory Affairs

For 20 years, our flagship publications, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips. Introducting the 10th edition of Fundamentals of US Regulatory Affairs, the cornerstone of a good regulatory library.

Navigate the complexities of the requirements and guidance's of healthcare product regulation in on comprehensive resource.